# K041698: Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Oct 5, 2004 after 105 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003227 (2001). 2 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003227: Bio-Absorbable Corkscrew Model AR-1920B, Arthrex, Inc. (2001) Summary page 1.
- K021883: Biofastin RC Threaded Suture Anchor, Mitek Worldwide (2002) Summary page 1.

## Most influential descendants
- K051983: Model 3000 Axyaloop Bio-Absorbable Bone Anchor (2005), 11 descendants of its own
- K051250: Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor (2005), 11 descendants of its own
- K060970: Axyaloop Nonabsorbable Bone Anchor (2006), 10 descendants of its own
- K083268: Tornier, Inc., Insite Suture Anchors (2009), 7 descendants of its own
- K110773: Tornier Insite FT Suture Anchor (2011), 5 descendants of its own

## Indications for use
The Axya Model 5000 AxyaLoop TM Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

Source page: https://510kreport.com/device/K041698
Methodology: https://510kreport.com/methodology